Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652321
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Endothelial Side Up Inverted Femtosecond Laser Assisted DSAEK
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Endothelial Side Up Inverted Femtosecond Laser Assisted DSAEK a Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the clinical outcomes pos toperative best corrected visual acuity endothelial count and anatomical results interface smoothness of DSAEK with Femto LDV-prepared grafts from the endothelial side
Detailed Description:
Corneal transplantation is the most frequently performed transplant surgery worldwide restoring visual function when corneal damage is severe Traditionally Penetrating Keratoplasty PKP was used to treat all forms of corneal blindness but it comes with potential complications such as graft rejection wound leaks and astigmatism To address these limitations Endothelial Keratoplasty EK emerged as a less invasive alternative particularly for conditions where only the corneal endothelium is compromised eg Fuchs endothelial dystrophy and pseudophakic bullous keratopathy
EK began with Posterior Lamellar Keratoplasty PLK and evolved through Descemets Stripping Endothelial Keratoplasty DSEK and Descemets Stripping Automated Endothelial Keratoplasty DSAEK which uses a microkeratome to create a thin corneal graft DSAEK however results in a meniscus-shaped graft with some degree of hyperopic shift postoperatively Another advancement Descemets Membrane Endothelial Keratoplasty DMEK uses only the donors Descemet membrane and endothelium providing better visual outcomes and fewer rejection risks Despite these benefits DMEK is technically challenging and unsuitable for some complex cases
Ultrathin UT DSAEK introduced sequential microkeratome cuts achieving graft thickness below 100 µm This approach offers faster visual recovery and comparable refractive outcomes to DMEK but with higher perforation risks during graft preparation Newer graft preparation methods such as femtosecond laser-assisted techniques have been introduced to improve consistency though deeper femtosecond laser cuts sometimes reduce accuracy due to laser scattering
This study proposes using Femto LDV Ziemer Ophthalmic Systems AG to prepare ultrathin DSAEK grafts from the endothelial side to ensure smoother interfaces and consistent graft thickness Previous in-vitro studies indicate that these grafts offer better endothelial protection and less damage when coated with Viscoat sodium chondroitin sulfate 40-sodium hyaluronate 30 compared to basic saline solution
Study Aim The goal of this pilot study is to evaluate the clinical outcomes best-corrected visual acuity endothelial cell count and anatomical outcomes interface smoothness of DSAEK with Femto LDV-prepared grafts
EK began with Posterior Lamellar Keratoplasty PLK and evolved through Descemets Stripping Endothelial Keratoplasty DSEK and Descemets Stripping Automated Endothelial Keratoplasty DSAEK which uses a microkeratome to create a thin corneal graft DSAEK however results in a meniscus-shaped graft with some degree of hyperopic shift postoperatively Another advancement Descemets Membrane Endothelial Keratoplasty DMEK uses only the donors Descemet membrane and endothelium providing better visual outcomes and fewer rejection risks Despite these benefits DMEK is technically challenging and unsuitable for some complex cases
Ultrathin UT DSAEK introduced sequential microkeratome cuts achieving graft thickness below 100 µm This approach offers faster visual recovery and comparable refractive outcomes to DMEK but with higher perforation risks during graft preparation Newer graft preparation methods such as femtosecond laser-assisted techniques have been introduced to improve consistency though deeper femtosecond laser cuts sometimes reduce accuracy due to laser scattering
This study proposes using Femto LDV Ziemer Ophthalmic Systems AG to prepare ultrathin DSAEK grafts from the endothelial side to ensure smoother interfaces and consistent graft thickness Previous in-vitro studies indicate that these grafts offer better endothelial protection and less damage when coated with Viscoat sodium chondroitin sulfate 40-sodium hyaluronate 30 compared to basic saline solution
Study Aim The goal of this pilot study is to evaluate the clinical outcomes best-corrected visual acuity endothelial cell count and anatomical outcomes interface smoothness of DSAEK with Femto LDV-prepared grafts
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None